Kornimate/medical-research-clean huggingface dataset:
car t therapy with gcar1 for relapsed alveolar soft part sarcoma

Conditions: Sarcoma; Alveolar Soft Part Sarcoma (ASPS)

Summary: a single patient study to determine whether gcar1 is safe and effective for re-treatment of alveolar soft part sarcoma (asps) with gpnmb surface expression that has relapsed and is not responding to usual treatment.

clic-yyc-gpnmb-04 is an open label individual patient (olip)/single patient study (sps) developed according to the health canada template and guidelines released in 2019 for studies to access therapies not otherwise available to patients, in the situation where there are no options of treatment or cure remaining. the patient under consideration for clic-yyc-gpnmb-04 has refractory, progressive metastatic alveolar soft part sarcoma (asps). there are no standard therapies for relapsed asps known to provide potential for cure, and there are no clinical trials available in canada for consideration. we propose to re-treat the patient with gcar1, a patient-specific cell therapy product containing a mixture of autologous lymphocytes transduced with a lentiviral vector containing a chimeric antigen receptor (car) that enables the specific targeting towards tumor cells expressing the cell surface protein glycoprotein non-metastatic b (gpnmb). the patient was previously treated with gcar1 under clic-yyc-gpnmb-01 (c#276646).

Eligibility criteria:
inclusion criteria: * the patient must provide informed consent * adequate organ function, defined as creatinine clearance \>30 ml/min and lvef \>45% exclusion criteria: * any active uncontrolled infection * pregnancy or nursing * anti-cancer therapy within 21 calendar days prior to the first dose of lymphodepleting chemotherapy. if subject has received anti-cancer therapy, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy as per the discretion of the qualified investigator/co-investigator

Keywords: car t gcar1
psychological screening and nursing of twin pregnancy

Conditions: Twin; Complicating Pregnancy; Psychology

Summary: objectives this research will screen the psychological problems of twin pregnant women step by step and detect early and treat early in order to reduce the incidence of mental diseases and promote the health of mother and baby.

method twin pregnant women recruited for the study.the two groups were given routine treatment and nursing measures. the trained group members were given routine psychological care to the control group, while the intervention group was given step-by-step psychological care at the same time. evaluate the effect 1. evaluation methods include process evaluation and result evaluation. process assessment means that the researchers use the pregnancy stress scale, self rating depression scale and self rating anxiety scale to assess the stress, anxiety and depression of patients at different stages, and make intervention decisions according to the score results; results evaluation means that if the intervention is effective at a certain stage, the researcher can use it again 2. the evaluation indexes included pps / sas / sds, incidence of preterm birth, premature rupture of membranes and blood pressure.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of intrauterine twin pregnancy. * the patients whose psychological screening scale score reached the critical value (pregnancy stress scale \>50 and/or self rating depression scale ≥ 40 and/or the self rating anxiety scale (sas) was more than 50. * the outpatient department of the research hospital was established and antenatal examination was carried out regularly. * no mental and communication disorders (including depression and other mental diseases). * voluntary participation in this study exclusion criteria: * pregnancy complicated with severe physical diseases; * drop out of this study due to various reasons (including abortion, unwilling to participate in this study)

Keywords: twin pregnancy psychological screening nursing
monoclonal antibody therapy in treating patients with refractory anaplastic large cell lymphoma or hodgkin's lymphoma

Conditions: Lymphoma

Summary: rationale: monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. purpose: phase i trial to study the effectiveness of monoclonal antibody therapy in treating patients with refractory anaplastic large cell lymphoma or hodgkin's lymphoma.

objectives: * determine the safety and tolerability of multiple doses of monoclonal antibody hefi-1 in patients with cd30+ anaplastic large cell lymphoma or hodgkin's lymphoma. * determine the pharmacokinetics of this drug in this patient population. * evaluate the efficacy, in terms of correlating immunologic parameters and immunogenicity, of this drug in these patients. outline: this is an open-label, dose-escalation study. patients receive monoclonal antibody hefi-1 iv over 30 minutes 3 times a week for 2 weeks. treatment may continue for 2 additional weeks in the absence of anti-hefi-1 response. responding patients may continue treatment at monthly intervals for one year. cohorts of 3-4 patients receive escalating doses of monoclonal antibody hefi-1 until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which 2 of 4 patients experience dose-limiting toxicity. patients are followed monthly. projected accrual: a total of 9 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed cd30+ anaplastic large cell lymphoma (alcl) or hodgkin's lymphoma * at least 50% of malignant cells must react with hefi-1 * hiv positive or hiv negative * measurable disease * no symptomatic cns disease * must have failed or be ineligible for standard chemotherapy regimen patient characteristics: age: * 18 and over performance status: * not specified life expectancy: * more than 2 months hematopoietic: * not specified hepatic: * no significant hepatic disease * bilirubin no greater than 2 mg/dl renal: * no significant renal disease * creatinine no greater than 3 mg/dl cardiovascular: * no significant cardiovascular disease pulmonary: * no significant pulmonary disease other: * no significant endocrine, rheumatologic, or allergic disease * no active clinical disease caused by cytomegalovirus (cmv), herpes simplex virus (hsv) i, hsv ii, hepatitis b, or tuberculosis * not pregnant * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * no prior murine antibody therapy chemotherapy: * see disease characteristics endocrine therapy: * not specified radiotherapy: * at least 4 weeks since prior radiotherapy to measurable disease surgery: * not specified other * at least 4 weeks since prior cytotoxic therapy to measurable disease

Keywords: recurrent adult hodgkin lymphoma anaplastic large cell lymphoma
z-drugs for sleep disorders in alzheimer's disease

Conditions: Sleep; Sleep Disorders; Insomnia; Alzheimer's Disease

Summary: the purpose of this study is to determine whether zolpidem and zoplicone are efective in the treatment of sleep disorders in alzheimer's disease (ad)

sleep disorders (sd) affects 35 to 50 percent of patients with ad. these disorders often make caring for patients at home very difficult. zolpidem and zoplicone are prescribed drugs for sleep disorder in ad patients.

Eligibility criteria:
inclusion criteria: * 55 years of age or older * diagnosis of probable alzheimer's disease (ad) by national institute of neurological and communicative disorders and stroke / the alzheimer's disease and related disorders association criteria * hachinski ischemia scale less than 5 * mini-mental state examination score of 0 to 26 * actigraph evidence of a mean time immobile of less than 7 hours per night based on at least 7 nights of complete actigraph data collected over a single week * four-week history of sleep disorder behaviors, occurring at least once weekly, as reported by the caregiver using the neuropsychiatric inventory (npi) nighttime behavior scale * sleep disturbance observed was not present before the diagnosis of ad * other co-morbidities, especially delirium, depression, chronic pain and medication use may be present, but do not cooperate in the primary symptoms * computed tomography or magnetic resonance imaging since the onset of memory problems showing no more than 1 lacunar infract in a nonstrategic area and no clinical events suggestive of stroke or other intracranial disease or normal * stable medications for 4 weeks prior to the screening visit * having a mobile upper extremity to which to attach an actigraph * residing with a responsible spouse, family member, or professional caregiver who is present during the night and would agree to assume the role of the principle caregiver for the 3-week protocol * ability to ingest oral medication and participate in all scheduled evaluations exclusion criteria: * sleep disturbance associated with an acute illness, delirium or psychiatric disease * clinically significant movement disorder, such as akinesia, that would affect actigraphic differentiation of sleep and wakefulness * severe agitation * unstable medical condition * discontinuation of psychotropic or sleep medication within 2 weeks of the screening visit * patient unwilling to maintain caffeine abstinence after 2:00pm for the duration of the protocol * patient unwilling to comply with the maximum limit of 2 alcoholic drinks per day, and only 1 alcoholic drink after 6:00pm for the duration of the protocolo * prior use of zolpidem/zoplicone for the treatment os sleep disturbances * caregiver deemed to be unreliable to supervise the wearing of the actigraph, to administer study capsules at the proper time, to maintain the sleep diary, or to bring the patient to the scheduled visits

Keywords: sleep disturbances alzheimer disease insomnia z-drugs treatment
prospective cardiac ultrasound imaging study with demonstrator

Conditions: Ventricular Tachycardia

Summary: the prospective cardiac ultrasound imaging study is a single center, single arm, feasibility study. the study aims at collecting cardiac ultrasound data from patients diagnosed with ventricular tachycardia, during rest and short breath hold sequences. this study is part of the engineering studies linked to the cardiokit-minimum viable product project. the cardiokit prototype used in the study can monitor cyclical heart-beat motion, cyclical respiratory motion and non-cyclical heart position changes while the patient is lying in supine position.

the research will analyse the ultrasound image data quality, especially investigating the ability of the prototype system to automatically and correctly interpret ultrasound images and artifact issues which may arise from age, body composition, mechanical valves, leads from implanted devices, or other implants. the study will establish if it is appropriate to develop a new medical device supporting automated cardiac ultrasound image interpretation during non-invasive cardiac procedures, i.e. ventricular tachycardia stereotactic radioablation. this early research protocol did collect data from 24 adult patients. the data were not used for diagnostic nor treatment purposes and the protocol's procedure duration was limited to one hour, hence the research was considered of very limited risk for the participants. the research will provide a proof-of-concept for a medical device to benefit patients with ventricular tachycardia and other cardiac pathologies in the future.

Eligibility criteria:
inclusion criteria: 1. patient with history of ventricular tachycardia 2. over 18 years old 3. ability and willingness to provide written informed consent exclusion criteria: 1. patient in arrhythmic storm

Keywords: artificial intelligence cardiac radioablation echocardiography motion monitoring ventricular arrhythmia
diphenhydramine for acute migraine

Conditions: Migraine

Summary: parenteral diphenhydramine is commonly used as adjuvant therapy for acute migraine despite the fact that data supporting this practice do not exist. the investigators propose a randomized double blind study to test the hypothesis that 50mg of intravenous diphenhydramine, when added to standard migraine therapy, will result in a greater rate of sustained headache relief than standard migraine therapy alone. for this study, standard migraine therapy will be 10mg of intravenous metoclopramide. sustained headache relief is defined as achieving a headache level of "mild" or "none" within two hours and maintaining a level of "mild" or "none" for 48 hours. patients who present to the montefiore emergency room (bronx, ny) with an acute migraine will be approached for participation. they will be screened for medication contra-indications and non-migraine etiologies of headache. the study will be randomized. assignment will be concealed. participants and researchers will be blinded. efficacy outcomes and adverse events will be assessed every half hour for two hours in the emergency department and by telephone 48 hours after medication administration. a sample size calculation, based on pilot data, revealed the need for 374 participants. an interim analysis will be performed after 200 participants have been enrolled with the goal of assessing for lack of conditional power.


Eligibility criteria:
inclusion criteria: * acute migraine headache * present to our emergency room in the bronx, ny for treatment of migraine headache exclusion criteria: * temperature \> 100.3 f * pheochromocytoma * seizure disorder * parkinson's disease * use of monoamine oxidase (mao) inhibitors * use of anti-rejection transplant medications * use of potassium supplements * use of pramlintide

Keywords: migraine headache metoclopramide diphenhydramine
a brief behavioral sleep intervention for depression among military veterans

Conditions: Insomnia; Depression; Suicidal Ideation

Summary: this study investigates the impact of brief behavioral insomnia treatment on depressive symptoms among military veterans.


Eligibility criteria:
* age 18 or older * veteran * insomnia symptoms * depression

Keywords: sleep insomnia suicidal symptoms suicidal ideation military veteran service member depression
arthrodesis versus extra-articular plate fixation in lisfranc injury

Conditions: Lisfranc Injuries

Summary: the purpose of this study is to compare arthrodesis of the first tmt-joint to extraarticular bridge plate fixation of the same joint in acute lisfranc injuries.

we want to compare arthrodesis of tmt 1 to temporary bridge plating of tmt 1 in acute lisfranc injuries where at least tarsometatarsal joints 1-3 are involved. we preform arthrodesis of tmt 2 and 3 in both groups.

Eligibility criteria:
inclusion criteria: * lisfranc injuries with instability off tmt1, and fracture/instability of tmt 2 and 3. no major fracture in relation to tmt1. * age 18-65 exclusion criteria: * feet with other major foot/ankle injuries * previous foot infection or foot pathology on affected side * previous surgery to the tmt joints * sequelae after previous foot injuries * diabetes mellitus, neuropathy and peripheral vascular disease
topiramate for alcohol use in posttraumatic stress disorder

Conditions: Alcohol Dependence; Alcoholism; Alcohol Abuse; Alcohol Use Disorder; PTSD; Posttraumatic Stress Disorder

Summary: alcohol abuse and dependence (alcohol use disorders, auds) and posttraumatic stress disorder (ptsd) are both prevalent in veterans. treating auds in veterans with ptsd may be more difficult than treating auds in the general population. the fda-approved medication topiramate has been shown to improve drinking outcomes in people with auds. topiramate has also improved symptoms in people with ptsd. this study is designed to investigate whether topiramate will improve drinking outcomes in veterans with ptsd.


Eligibility criteria:
inclusion criteria: * male * ages 21-64 * diagnosis of ptsd via a score of 50 or higher on the clinician administered ptsd scale (caps) * alcohol abuse or dependence per diagnosis in the medical record -or- by consuming more than 35 standard drinks per week over the previous 4 weeks as measured by the timeline follow-back interview * a desire to reduce drinking behavior * any race/ethnicity exclusion criteria: * currently taking a carbonic anhydrase inhibitor (e.g. zonisamide, acetazolamide, dichlorphenamide) * currently taking or have taken in the previous 3 months: acamprosate, naltrexone, disulfiram, topiramate * change in benzodiazepine dose within the previous 3 months * change in other (non-benzodiazepine) medication dose within the last 4 weeks * seizure disorder documented in the medical record * head trauma with loss of consciousness for greater than 30 minutes -or- a diagnosis of post-concussive syndrome documented in the medical record * suicide attempt within the previous 3 months or suicidal ideation within the previous 4 weeks * a history of kidney stones * a history of glaucoma * alt or ast liver enzymes elevated more than twice the upper limit of normal * more than 4 unsuccessful attempts at inpatient alcohol treatment * medically unstable (including significant hypertension despite adequate treatment) * a history of delirium tremens ("dts") or alcohol withdrawal seizure * compulsory treatment to avoid legal consequences (e.g. imprisonment) * currently in a setting without access to alcohol (e.g. locked inpatient unit)

Keywords: topiramate ptsd drinking alcohol
a prospective observational study comparing computer-assisted paramedian approach versus conventional midline approach for lumbar puncture

Conditions: Spinal Puncture

Summary: the goal of this clinical trial is to compare the effects of cmpat and mat in patients undergoing lp. participants will be randomly assigned to either the cmpat treatment group (group a) or the mat treatment group (group b). researchers will compare cmpat treatment group and the mat treatment group to see if the number of needle insertion attempts required for a successful lp, the puncture success rate, pain assessment in the back, head, and legs, and the occurrence of complications have different.


Eligibility criteria:
inclusion criteria: * aged 18-99 years. indication for lumber puncture (diagnostic lumbar puncture, analysis of cerebrospinal fluid composition, measurement of cerebrospinal fluid pressure, release of cerebrospinal fluid, lumbar cistern drain-age or intrathecal injection). body mass index between 18.5 and 35 kg/m2. exclusion criteria: * cerebral hernia or known high cerebrospinal fluid pressure prone to cerebral hernia. * oral anticoagulant or antiplatelet therapy (≤3 days) or coagulation dysfunction, various factors lead to a higher risk of bleeding. * active infection or prior infection at the surgical site. * skin breakdown. * previous spine fusion surgery. * cauda equina syndrome. * pregnancy or breast feeding. * severe comorbid medical or psychiatric disorder. * unwilling to adhere to any of the required procedures. * cognitive impairment interfering with participant's ability to give full and - - informed consent or complete the baseline or follow-up assessments. * survival expectation less than 1 month. * moving abroad in 1 month.

Keywords: computer modified paramedian approach technique, lumbar puncture, midline approach technique, puncture attempts, pain
usability of a multimodal external neuromodulatory device to relieve acute low back pain

Conditions: Low Back Pain; Low Back Sprain; Low Back Pain, Recurrent

Summary: ten patients with acute or chronic low back pain will be invited to try a multimodal device for 20 minutes. pain will be recorded prior to and after use, and feedback on the device will be elicited.

to facilitate data collection of a short-term intervention, the investigators chose to enroll patients from a mixed physical therapy/chiropractic practice with demographic and economic diversity in the metro washington area. the neuromodulatory device will have patient controlled frequencies at 50hz, 100hz, and 180hz attached to a 12 x 22 cm metal plate ergonomically curved to fit the low back. the device will be wearable with a neoprene belt on both sides for patients to adjust pressure. the metal pocket in our device holds a 221g clay pack capable of being frozen to 15f or heated to 110f or patient tolerance, with 30 minute thermal capacity. a convenience sample of 10 patients at the clinic was invited to give feedback on the prototype device after informed consent. changes suggested were incorporated and after informed consent a second group of ten gave will give feedback with the production-ready device.

Eligibility criteria:
inclusion criteria: * acute or chronic low back pain as chief complaint * capacity to understand all relevant risks and potential benefits of the study (informed consent); * willingness to communicate information exclusion criteria: * radicular pain likely reflecting a surgical or mechanical problem * bmi greater than 30 (device won't fit) * sensitivity to cold or vibration (e.g raynaud's or sickle cell disease) * diabetic neuropathy rendering a patient unable to determine if the device is too hot * new neurologic deficits * skin lesions over the low back area * contraindication to any medication for pain management that would impact analgesic use record * inability to apply duotherm

Keywords: medical device buzzy vibration thermomechanical